Plant Setup & Design

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From concept to commissioning — complete execution under one roof

We offer end-to-end turnkey project execution for sterile and non-sterile pharmaceutical manufacturing plants. This includes concept design, feasibility assessment, detailed engineering, construction oversight, validation, and final handover.

Whether you're launching a new facility or upgrading an existing one, we ensure full compliance with US FDA, EU GMP, WHO, and global regulatory frameworks, delivering audit-ready and future-proof facilities.

Our Turnkey Services Include:

• Site evaluation and feasibility studies
• Project planning and budgeting
• Conceptual & detailed engineering
• Cleanroom and classified area construction
• Equipment procurement and installation
• Qualification & validation (DQ, IQ, OQ, PQ)
• Documentation and QMS setup
• Regulatory audit preparation
   

Outcome: A fully compliant and operational facility ready for production and regulatory inspection — delivered with transparency, efficiency, and technical accuracy.

Designs that simplify compliance and support long-term growth

We specialize in creating modular, scalable, and inspection-ready pharmaceutical facilities. Our layouts are based on cleanroom classification (ISO 14644), EU GMP zoning principles, and contamination control strategies. Each design is customized to support the client's process flow, product type, and regulatory target market.

Key Design Features:

• Cleanroom zoning and classification
• Unidirectional flow of personnel and materials
• Logical separation of clean and dirty zones
• HVAC zoning integrated into layout
• Expandable design for future capacity
• Alignment with compliance guidelines
   

Benefit: A compliant facility layout that enhances operational efficiency, minimizes cross-contamination risks, and ensures smooth inspections.

Clean utilities designed for consistency, reliability, and compliance

We provide cost-effective, robust, and compliant utility system designs for critical pharmaceutical environments. Our solutions ensure that environmental conditions, water systems, and process utilities meet stringent global regulatory and quality standards.

Our Utility Design Expertise Covers:

• HVAC systems for Grade A/B/C/D cleanrooms
• AHU zoning and air balancing
• Purified Water (PW), Water for Injection (WFI), and Pure Steam loop design
• Compressed Air, Nitrogen, and other process gas systems
• Utility qualification and validation protocols
• Integration with Building Management Systems (BMS)
• Energy-efficient and low-maintenance design
   

Value Delivered: Reliable utility systems—both clean and process—that support aseptic and non-sterile manufacturing, pass regulatory validation, and meet global GMP requirements.

Fit-for-purpose equipment and efficient layouts — built for compliance and productivity

We support clients in selecting the right equipment aligned with their process needs, regulatory expectations, and available resources. Our services also include preparation of URS (User Requirement Specifications) and layout planning for optimal space usage and process flow.

Our Scope Includes:

• URS development based on process, cleaning, and validation needs
• Vendor evaluation and equipment sourcing
• Equipment layout to support:
  • Cleaning & sanitization
  • Process flow
  • Validation access
  • Cross-contamination control 
• Support in FAT/SAT, DQ/IQ/OQ
   

Our Focus: To help you build a facility that runs efficiently, passes audits, and meets production goals — without overengineering or overspending.